Biosimilars & Generic Drugs Pre-Master’s Certificate

The Biosimilars & Generic Drugs Pre-Master’s Certificate in Temple’s School of Pharmacy gives graduate students the framework to understand how generic drugs are manufactured and regulated on the local, national and global levels. The certificate is part of Temple’s Regulatory Affairs and Quality Assurance (RAQA) graduate program, which is based in Fort Washington, Pennsylvania, approximately 20 miles from the Health Sciences Center in North Philadelphia. Courses take place on evenings and weekends to accomodate the schedules of working professionals.

The Biosimilars & Generic Drugs program focuses on the unique dynamics of generic drug distribution throughout the world. The curriculum delves into four key areas.

  • Domestic and global regulations for generic products
  • The global business environment
  • Good distribution practices
  • Manufacturing science

Starting with an overview of the drug development process, this certificate explores the global marketplace for generic drugs and biopharmaceuticals, building a strong foundation in generic regulatory issues. This includes exploring the Abbreviated New Drug Application process as well as analyzing both domestic and global distribution practices. The courses also immerse students in current trends and controversies facing the generic drug industry, including

  • authorized generics,
  • citizens’ petitions, and
  • generic initiative for value and efficiency.

Students who complete the certificate requirements have the option to apply credits toward the Master of Science in Regulatory Affairs and Quality Assurance.

Classes & Curriculum

The certificate consists of five courses, which you can take on a part-time basis, with four years to complete the certificate. Required courses include

  • Drug Development and 
  • Generic Drug Regulation: ANDAs.

Beyond the required courses, you may select electives like these.

  • Analytical Chemistry in Pharmaceutical Laboratories
  • Biologics/Biosimilars: A Regulatory Overview
  • The Global Biopharmaceutical Industry (including Waxman Hatch)
  • Global CMCs for Biologics
  • Good Distribution Practices
  • Global Pharmaceutical Excipient Regulation
  • Pharmaceutical Manufacturing II

See the full list of courses for the Biosimilars and Generic Drugs certificate.

Related Graduate Degrees

Related Graduate Certificates

Career Opportunities 

Alumni and current students of the Regulatory Affairs and Quality Assurance graduate program can join the job postings listserv to gain access to current career opportunities.

Career Night
Regulatory Affairs and Quality Assurance hosts an annual career night for students to meet with representatives from at least a dozen actively hiring companies. The evening features presentations on topics for breaking into the industry and gaining employment, such as interviewing tips and resume writing.

Students are also encouraged to speak with Regulatory Affairs and Quality Assurance faculty about their professional goals and ambitions.

Delivery Method

The Master of Science in Global Clinical and Pharmacovigilance, Master of Science Non-Thesis in Pharmaceutical Sciences, Master of Science in Regulatory Affairs and Quality Assurance, and most certificates can be completed in-person at Temple’s Fort Washington location or online. The Regulatory Affairs and Quality Assurance graduate program offers more than 60 elective courses online.

Online courses in the RAQA program are offered in real time. You’ll participate in classes each week at a specific time, watching live lectures given by your instructor through interactive platforms. This format enables you to interact with other professionals across the country and world.

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this Graduate Certificate offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more. These tuition costs apply to the 2020–2021 academic year.

Pennsylvania resident: $1,072.00 per credit
Out-of-state: $1,358.00 per credit

Learn more about our tuition and fees.


Additional Program Information